The United States Food and Drug Administration (FDA) has completed our evaluation of the corrective actions you took in response to Warning Letter FLA-10-01 issued to your firm on October 8, 2009. As verified during a, reinspection of your firm on March 1 and 2, 2010, it appears that you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Please be advised that this letter neither relieves you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations nor does it preclude any future regulatory action(s) (e.g., seizure and/or injunction) should violations be observed during subsequent inspections or through other means. FDA expects your continued compliance with the Act and will monitor the status of your compliance accordingly.